Asmakast 10 mg 30 tablets

Asmakast 10 mg 30 film-coated tablets

Composition

Each tablet contains:

Montelukast sodium 10.4 mg (equivalent to 10 mg montelukast)

Excipient with known effect: lactose monohydrate 89.1 mg

For the full list of excipients, see section 6.1.

Description

Asmakast is an anti-asthmatic agent and a selective leukotriene receptor antagonist. It is used for controlling and preventing asthma symptoms, relieving seasonal allergic rhinitis, and preventing exercise-induced bronchoconstriction.

Indications for Use

-Treatment of mild to moderate persistent asthma in patients inadequately controlled on inhaled corticosteroids.

-Relief of seasonal allergic rhinitis symptoms in asthmatic patients.

-Prevention of exercise-induced bronchoconstriction.

Dosage and Method of Administration

-Recommended dose for adults and adolescents aged 15 years and older: one 10 mg tablet daily in the evening.

-Swallow the tablet with water, with or without food.

-Not for use in children under 15 years.

Contraindications

Hypersensitivity to montelukast or any excipients.

Hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.

Precautions

-Neuropsychiatric events (depression, aggression, suicidality) may occur.

-Not indicated for acute asthma attacks.

-Keep rescue medications available.

-Risk of Churg-Strauss syndrome if oral corticosteroids are reduced.

-Not for patients with lactose intolerance.

-This product is essentially sodium-free.

Side Effects

Very common: upper respiratory tract infections

Common: rash, elevated transaminases

Uncommon: insomnia, anxiety, dizziness, arthralgia

Rare/very rare: angioedema, hepatitis, eosinophilia, vasculitis, hallucinations, depression, seizures, tics

Pregnancy and Breastfeeding

Use only if clearly essential. Montelukast is excreted in animal milk; unknown in humans.

Storage Conditions

Store below 30°C in a dry place.

Packaging

Carton box containing 3 blisters of 10 tablets with package leaflet.